Rapid-melt semi-solid compositions, methods of making same and methods of using same

ABSTRACT

A novel rapid-melt, semi-solid molded composition, including methods of making the same, and methods of using the same for the delivery of prophylactic and therapeutic active materials to a mammal wherein the prophylactic or therapeutic active is a psychotropic, a gastrointestinal therapeutic or a migraine therapeutic.

BACKGROUND OF THE INVENTION

[0001] 1. Field of the Invention

[0002] The present invention relates to a rapid-melt, semi-solidcomposition for delivery of prophylactic and therapeutic activematerials to a mammal, methods of making the same, and methods of usingthe same. Preferably, the prophylactic or therapeutic active is apsychotropic, a gastrointestinal therapeutic or a migraine therapeutic.

[0003] 2. Description of the Prior Art

[0004] Pharmaceutical compositions may be produced in a variety ofdosage forms, depending upon the desired route of administration of thetherapeutic material. Oral dosage forms, for example, include such solidcompositions as tablets, emulsions, and suspensions. The particulardosage form utilized will depend on such factors as the solubility andchemical reactivity of the pharmaceutical active. Further, the dosageform may be selected so as to optimize delivery of the pharmaceuticalactive and/or consumer acceptability of the composition.

[0005] Tablet compositions offer many advantages, including ease ofproduct handling, chemical and physical stability, portability (inparticular, allowing ready availability to the consumer when needed),aesthetic acceptability and dosage precision, i.e., ensuring consistentand accurate dosages of the pharmaceutical active. However, liquidformulations may offer advantages in the treatment of certain disorders,such as disorders of the upper gastrointestinal tract, wherein deliveryof an active material dissolved or dispersed in a liquid ensures rapidand complete delivery to the afflicted area. In an effort to obtain thetherapeutic advantages associated with liquid formulations as well asthe broad advantages associated with solids, many chewable tabletformulations have been developed.

[0006] One important factor in formulating chewable tablets ispalatability and mouth feel, especially in tablets that includepharmaceutical dosages. Many pharmaceutical and confectionery tabletsare designed to be chewed either to provide proper flavor or to increasethe surface area of a particular drug to permit rapid activity in thedigestive tract or circulatory systems. However, many pharmaceuticalingredients usually have both an unpleasant mouth feel and unpalatabletaste due to chalkiness, grittiness, dryness and astringent propertiesof these materials. Accordingly, the practical value of these materialsis substantially diminished since patients finding them objectionablemay fail to take them as prescribed. A number of formulations have beeninvestigated to ease the mouth feel and palatability of suchcompositions.

[0007] Khankari et al., U.S. Pat. No. 6,024,981, discloses a rapidlydissolving robust dosage form directed to a hard tablet that can bepackaged, stored and processed in bulk. The solid tablet dissolves inthe mouth of a patient with a minimum of grit. The tablet contains anactive ingredient mixed into a matrix of a non-direct compression fillerand a relatively high lubricant content.

[0008] Amselem, U.S. Pat. No. 5,989,583, discloses a dry solid lipidcomposition suitable as an oral dosage form. The composition contains alipophilic substance, at least one fat which is a solid at about 25° C.and at least one phospholipid present in an amount of about 2 to 40% byweight of the composition. However, the resultant product is a dry solidlipid composition.

[0009] United Kingdom patent application GB 2 195 892 disclosespharmaceutical chewable tablets with improved palatability. Thelipid-containing molded tablets include a lipid material having amelting point from about 26° C. to about 37° C., a particulatedispersant material, an emulsifier and a safe and effective amount of apharmaceutically active material. The tablets of the lipid compositionexhibit improved palatability, and effective dispersion in the mouth andstomach.

[0010] United Kingdom patent application GB 2 195 891 also disclosespharmaceutical chewable tablets with improved palatability. Thelipid-containing molded tablets include a lipid material, a dispersant,a nonionic emulsifier having an HLB of at least 10, and a safe andeffective amount of a pharmaceutical active material, wherein theaverage HLB of all emulsifiers in the composition is at least about 8.

[0011] Nakamichi et al., U.S. Pat. No. 5,837,285, discloses fast solubletablets that can be produced by a simple method. The tablet base is asugar alcohol. The mixture of the sugar alcohol and a drug is subjectedto compressive shaping prior to drying in the process. The dry solidtablet can be produced by modification of conventional tabletingtechnology and possesses physicochemical stability.

[0012] Chavkin et al., U.S. Pat. No. 5,753,255 discloses a chewablemedicinal tablet. The tablet contains about 30 to about 95% by weight ofa capric triglyceride and a medicinally active ingredient up to 60% byweight. If the medicinally active ingredient is less than about 30% byweight, then the composition also contains up to 10% by weight of amember of the group consisting of glyceryl monostearate, a mixture ofglyceryl monostearate and glyceryl monopalmitate, and a mixture ofglyceryl monostearate and glyceryl distearate.

[0013] Geyer et al., U.S. Pat. No. 5,320,848, discloses a non-aqueouschewable composition for oral delivery of unpalatable drugs. The drug isintimately dispersed or dissolved in a pharmaceutically-acceptable lipidthat is solid at room temperatures. The lipid material desirably readilymelts with the application of mild temperatures, i.e. about 55 to 95° C.

[0014] Lapidus, U.S. Pat. No. 4,937,076, discloses a chewable aspirinand buffering material tablet in a single dosage form. The bufferingmaterials are integrally dispersed and bound in a fatty material ofchocolate, synthetic chocolate or hydrogenated tallow. The fattymaterial individually coats the aspirin and buffering material.

[0015] Valentine, U.S. Pat. No. 4,684,534, discloses quick-liquefying,chewable tablets. The tablets have a harder outer shell which inhibitspenetration of liquid, and a softer interior which quickly liquefieswhen the tablet and shell are broken into pieces and contacted by theliquid. The excipient or base material of the tablet is made fromcarbohydrates held together with small quantities of a carbohydratebinder such as maltodextrin. The tablets can contain active ingredientssuch as pharmaceuticals, breath sweeteners, vitamins and dietarysupplements.

[0016] Morris et al., U.S. Pat. No. 4,609,543, discloses a softhomogeneous antacid tablet. The tablet contains solid antacid particlesthoroughly coated with a mixture composed of a fatty material or oil, asurfactant, and a flavor. The fat or oil is present in an amount of fromabout 25% to about 45% of the mixture. The primary particle size of theantacid is less than 100 millimicrons.

[0017] Fountaine, U.S. Pat. No. 4,446,135, discloses chewable calciumcarbonate-containing antacid tablets having good mouth feel properties.The good mouth feel properties of the tablet are obtained by usingcalcium carbonate of a particular particle size in combination withcertain excipients. The calcium carbonate is present in an effectiveamount and has a size from about 5 to 50 microns in diameter.

[0018] Puglia et al., U.S. Pat. No. 4,327,077, discloses a compressedchewable antacid tablet which has good flexibility, is breakageresistant and disintegrates immediately upon chewing. The tablet isformed of a recrystallized fatty material, such as chocolate, a bulkingmaterial and an active ingredient bound up in the particles of therecrystallized fatty material. The preferred recrystallized fattymaterial is a chocolate or a synthetic chocolate.

[0019] Puglia et al., U.S. Pat. No. 4,327,076, also discloses acompressed chewable antacid tablet which has good flexibility, isbreakage resistant and disintegrates immediately upon chewing. Thetablet is formed of particles of the antacid or other active ingredientwhich are admixed with particles formed of edible fat or oil absorbed ona fat-absorbing material, such as microcrystalline cellulose. Uponchewing, the tablet is quickly converted to a smooth creamy non-grittypalatable emulsion.

[0020] However, the prior art compositions contain variousdisadvantages. For example, tablets may be incompletely chewed due tothe poor palatability of the composition. Such compositions may alsohave a gummy texture, and are subject to “taste fatigue,” i.e., thecomposition is perceived to be less palatable after ingestion ofmultiple doses. Further, the binders and other materials used in suchchewable tablets may prevent rapid and effective delivery of activematerials to the stomach.

[0021] There is a need for a rapid-melt, semi-solid composition thatbehaves like a liquid when consumed by a mammal, and yet acts like asolid in many other ways. The need extends for compositions in which nobiting or chewing is necessary in order for the composition to melt inthe mouth of a mammal. Such compositions are ideal for uses in thefields of pediatric and geriatric care, that is, for use with people ormammals that do not have any teeth.

[0022] It has been found that semi-solid product formulations containingone or more certain lipid materials, emulsifiers and particulatematerials are highly palatable and effective compositions for thedelivery of pharmaceutical active materials. Such compositions affordbetter taste, mouth feel and storage stability than those compositionsknown in the art.

BRIEF SUMMARY OF THE INVENTION

[0023] Applicant has unexpectedly developed a novel rapid-melt,semi-solid molded composition comprising:

[0024] a) at least one binder in an amount from about 0.01% to about 70%by weight;

[0025] b) a salivating agent in an amount from about 0.05% to about 15%by weight;

[0026] c) a diluent/bulking material in an amount from about 10% toabout 90% by weight; and

[0027] d) an active material in an amount from about 0.001% to about 70%by weight;

[0028] wherein the composition is prepared in the absence of free water.

[0029] Applicant has further developed a novel method of preparing arapid-melt, semi-solid molded composition comprising the steps of:

[0030] a) melting at least one binder in an amount from about 0.01% toabout 70% by weight with a salivating agent in an amount from about0.05% to about 15% by weight, to form a mixture

[0031] b) mixing an active material with said mixture to form an activemixture;

[0032] c) mixing a diluent/bulking material with said active mixture toform a final mixture; and

[0033] d) molding said final mixture into said semi-solid moldedcomposition.

[0034] Further, Applicant has unexpected developed a novel rapid-melt,semi-solid molded composition comprising:

[0035] a) at least one binder in an amount from about 0.01% to about 70%by weight;

[0036] b) a salivating agent in an amount from about 0.05% to about 15%by weight;

[0037] c) a diluent/bulking material in an amount from about 10% toabout 90% by weight;

[0038] d) water in an amount less than 2% by weight; and

[0039] e) an active material in an amount from about 0.001% to about 70%by weight.

[0040] In addition, Applicant has developed a rapid melt, semi-solidmolded composition comprising:

[0041] at least one binder in an amount from about 0.01% to about 70% byweight;

[0042] a salivating agent in an amount from about 0.05% to about 15% byweight;

[0043] a diluent/bulking material in an amount from about 10% to about90% by weight; and

[0044] a therapeutically effective amount of a drug, wherein said drugis selected from the group consisting of psychotropics, gastrointestinaltherapeutics, cardiovascular therapeutics, migraine therapeutics,inflammation therapeutics, benign prostatic hypertrophy therapeutics,fungal therapeutics, allergic rhinitis therapeutics, anticonvulsants,and viral therapeutics.

[0045] Further, Applicant has developed a method of preparing arapid-melt, semi-solid molded composition comprising the steps of:

[0046] a) melting at least one binder in an amount from about 0.01% toabout 70% by weight with a salivating agent in an amount from about0.05% to about 15% by weight, to form a mixture;

[0047] b) mixing a therapeutically effective amount of a drug with saidmixture to form an active mixture; said drug selected from the groupconsisting of psychotropics, gastrointestinal therapeutics,cardiovascular therapeutics, migraine therapeutics, inflammationtherapeutics, benign prostatic hypertrophy therapeutics, fungaltherapeutics, allergic rhinitis therapeutics, anticonvulsants, and viraltherapeutics.

[0048] c) mixing a diluent/bulking material with said active mixture toform a final mixture; and

[0049] d) molding said final mixture into said rapid-melt, semi-solidmolded composition.

[0050] Still further, Applicant has developed a method for treatingdepression, anxiety or insomnia comprising the step of administering toa patient in need thereof a pharmaceutical composition comprising:

[0051] at least one binder in an amount from about 0.01% to about 70% byweight;

[0052] a salivating agent in an amount from about 0.05% to about 15% byweight;

[0053] a diluent/bulking material in an amount from about 10% to about90% by weight;

[0054] a therapeutically effective amount of an anti-depressant,anti-anxiety therapeutic or an insomnia therapeutic and wherein saidcomposition is prepared in the absence of free water.

[0055] Yet still further, Applicant has developed a method for treatingdiarrhea and nausea comprising the step of administering to a patient inneed thereof a pharmaceutical composition comprising:

[0056] at least one binder in an amount from about 0.01% to about 70% byweight;

[0057] a salivating agent in an amount from about 0.05% to about 15% byweight;

[0058] a diluent/bulking material in an amount from about 10% to about90% by weight;

[0059] a therapeutically effective amount of an gastrointestinaltherapeutic, a anti-emetic or an anti-diarrheal therapeutic and whereinsaid composition is prepared in the absence of free water.

[0060] Even yet still further, Applicant has developed a method fortreating migraines comprising the step of administering to a patient inneed thereof a pharmaceutical composition comprising:

[0061] at least one binder in an amount from about 0.01% to about 70% byweight;

[0062] a salivating agent in an amount from about 0.05% to about 15% byweight;

[0063] a diluent/bulking material in an amount from about 10% to about90% by weight;

[0064] a therapeutically effective amount of an migraine therapeutic andwherein said composition is prepared in the absence of free water.

[0065] The rapid-melt, semi-solid molded compositions of the presentinventive subject matter exhibit good resistence to prolonged exposureto heat and the atmosphere. More particularly, the compositionssurprisingly maintain their texture and rapid melting properties whenexposed to those elements.

DETAILED DESCRIPTION OF THE EMBODIMENTS

[0066] The rapid-melt, semi-solid molded compositions of the presentinventive subject matter contains at least one binder, a salivatingagent, an active material, and a diluent/bulking material. Therapid-melt, semi-solid compositions may also contain a slipping agent toaid in the transport of the composition from the mouth of the mammal tothe stomach thereof.

[0067] As used herein, the expression “mammal” includes withoutlimitation any mammalian subject, such as mice, rats, guinea pigs, cats,dogs, human beings, cows, horses, sheep or other livestock.

[0068] As used herein, the expression “free water” means water that isnot found in other ingredients. Many ingredients used in the presentinventive compositions may also have water as part of the ingredient,and the term “free water” refers to water that is separate from thoseingredients.

[0069] The unique novel combination of elements allows for fast meltingof the composition when placed in the mouth of a user. By pressing thecomposition between the tongue and cheek of the user, the saliva of theuser provides hydration to the composition and allows the composition tomelt without any chewing. A unique feature of the present inventivecompositions is that the composition becomes a liquid upon theapplication of pressure. The semi-solid compositions rapidly melt uponthe application of pressure by the tongue of the patient, thus forming aliquid carrier for the active ingredients contained therein. The liquidhelps provide the unique characteristics and features of the presentinventive compositions.

[0070] The liquification of the inventive compositions can be achievedthrough the application of pressure by the tongue of the patient, asdescribed above. Optionally, the liquification may be attained by thepatient chewing the compositions. A slight amount of chewing willenhance the liquefication of the compositions. A further way for thecomposition to be liquified is by the patient sucking on the rapid-melt,semi-solid compositions of the inventive subject matter.

[0071] The rapid-melt, semi-solid technology of the present inventivesubject matter has multiple applications which are ideal for the uniqueproperties of the compositions. One such application is the delivery ofactive ingredients to a mammal in need thereof.

[0072] In addition, the melting feature of the novel compositions makesthe compositions ideal for uses in pediatric and geriatric care, sincesmall children and aged individuals often have difficulty chewing items.With this intended use in mind, the compositions may be speciallyformulated for pediatric and geriatric patients. The unique propertieswill aid in drug compliance by such patients as the drugs may beadministered in a way that will not require chewing by the patient.

[0073] Another application for which the inventive compositions areideal is to enhance the saliva flow of a patient. A frequent problem forgeriatric patients is dry-mouth, or the inability to salivatesufficiently. The aid of saliva flow by the use of the present inventivecompositions will enhance tooth cleaning within the patient, as well asstimulate better drug delivery to the patient. Also, the increasedsaliva flow will facilitate better breath characteristics in thepatient. The use of xylitol, as well as other polyols and sugars, in theinventive compositions will contribute to the enhancement of the salivaflow of the patient.

[0074] A further application for the inventive compositions would be thepreparation of compositions for drug delivery in diabetic patients. Adiabetic patient must monitor the intake of sugar and the ability toformulate the present inventive compositions with fractose and othernon-cariogenic components makes them ideal for delivery of drugs todiabetic patients.

[0075] The rapid-melt, semi-solid compositions of the present inventivesubject matter are preferably anhydrous, that is, they do not containany water. The lack of water in the inventive compositions allows highdoses of active materials or combinations of active materials to beincorporated into the compositions due to the stability of the activematerials in the absence of the water. It is contemplated, however, thatthe compositions may optionally include an amount of water. The amountof water present will depend on the active ingredients to be delivered,but generally will be present in an amount less than 2.0% by weight ofthe composition. Preferably, the water will be present in an amount lessthan 1.0% by weight of the composition.

[0076] The rapid-melt, semi-solid compositions of the present inventivesubject matter contain at least one binder. As used herein, “binder”means at least one ingredient useful in keeping the composition in itssemi-solid state, may be either solid or liquid, and may include,without limitation, a high melting point fat or waxy material such aslipid materials, polyethylene glycols (PEG), waxes and other fats.Preferably, the semi-solid compositions of the present inventive subjectmatter contains a mixture of binders. The solid binders useful in thecompositions of the present inventive subject matter have a meltingpoint of about 25 to 90° C., and preferably about 37° C. When more thanone binder is used in the inventive compositions, the melting point ofthe combination of the binders will remain within the range of 25 to 90°C., and preferably about 37° C. The inventive subject mattercontemplates the use of mixtures of solid binders and liquid binders.For a non-limiting example, the present inventive subject mattercontemplates mixing a small amount of a high-melting point lipid with aliquid binder to achieve a binder that attains the desired productcharacteristics. These characteristics include such factors as mouthfeel, rapidity of melting in the mouth, appearance, flavor andcompatibility with active materials and therapeutic active materials.

[0077] Among the lipid materials useful as binders in the compositionsof the present inventive subject matter are those which are commerciallyavailable and commonly used in confectionery and other food products.Such lipid materials include, without limitation, cocoa butter,hydrogenated tallow, hydrogenated vegetable oils, hydrogenated cottonseed oil, palm kernel oil, soybean oil, stannol esters, and derivativesand mixtures thereof. Hydrogenated vegetable oils (such as hydrogenatedpalm kernel oil), cocoa butter, and cocoa butter substitutes are amongthe preferred useful lipid materials.

[0078] Other materials are also suitable as binders in the presentinventive subject matter. Included within the materials suitable asbinders are, without limitation, polyethylene glycols and liquidbinders. Examples of liquid binders are, without limitation, polysaccharides, gum solutions, water, corn syrup, hydrogenated starchhydrolates, glycerine, polypropylene glycol, and mixtures thereof.

[0079] The amount of binder present in the rapid-melt, semi-solid moldedcomposition of the present inventive subject matter is from about 0.01%to about 70% by weight of the final composition. Preferably, the amountof binder is from about 0.01% to about 50% by weight of the composition.More preferably the binder is present from about 15% to about 30% byweight of the composition.

[0080] The binder is used to provide good melt away properties to thecomposition while preventing a gritty texture being imparted by thecomposition. The binder aids in the fast melting of the composition whenplaced in the mouth of a user.

[0081] The rapid-melt, semi-solid molded composition of the presentinventive subject matter also contains a salivating agent. As is usedherein, “salivating agent” means a material that promotes greatersalivation in the user of the compositions of the present inventivesubject matter. The salivating agent helps create salivation in themouth of the mammal using the inventive compositions. This is animportant feature since the present compositions are intended to betaken by the patient without the aid of water to help in thetransporting of the composition to the stomach of the patient. Thesalivating agent can be, without limitation, an emulsifier or a foodacid that initiates salivation in the mouth of the patient.

[0082] Examples of emulsifiers useful as salivating agents in thecompositions of the present inventive subject matter include, withoutlimitation, alkyl aryl sulfonates, alkyl sulfates, sulfonated amides andamines, sulfated and sulfonated esters and ethers, alkyl sulfonates,polyethoxlyated esters, mono- and diglycerides, diacetyl tartaric estersof monoglycerides, polyglycerol esters, sorbitan esters and ethoxylates,lactylated esters, phospholipids such as lecithin, polyoxyethylenesorbitan esters, proplyene glycol esters, sucrose esters, and mixturesthereof. The emulsifier may be either saturated or unsaturated.

[0083] Examples of food acids useful as salivating agents in theinventive compositions include, without limitation, citric acid, malicacid, tartarate, food salts such as sodium chloride and saltsubstitutes, potassium chloride, and mixtures thereof.

[0084] The amount of salivating agent present in the rapid-melt,semi-solid molded composition of the present inventive subject matter isfrom about 0.05% to about 15% by weight of the final composition.Preferably, the amount of salivating agent from about 0.3% to 0.4% byweight of the composition.

[0085] Keeping the amount of salivating agent present in the inventivecomposition within these limits for weight percentage is important toenhance the desirable properties of the compositions. More particularly,the low amount of salivating agent present in the compositions aid inthe compositions retaining the semi-solid state and the rapidity ofmelting in the mouth of a mammal.

[0086] The rapid-melt, semi-solid molded compositions of the presentinventive subject matter further contain a diluent/bulking material. Theuse of a diluent/bulking material is necessary to serve as a free-flowimparting agent which aids in the moisturizing of the composition whenchewed, that is, the diluent/bulking material aids in the processabilityof the compositions. The diluent/bulking material also serves to reducethe concentration of the active materials and add bulk to thecomposition. Examples of diluent/bulking materials useful in thecompositons of the present inventive subject matter include, withoutlimitation, silicon dioxide, sugars, starches, lactose, sucrose,sorbitol, fructose, talc, stearic acid, magnesium stearate, dicalciumphosphate, erythitol, xylitol, mannitol, maltitol, isomalt, dextrose,maltose, lactose, microcrystalline celluloses and mixtures thereof.

[0087] The amount of diluent/bulking material present in the semi-solidmolded compositions is from about 10% to about 90% by weight of thefinal composition. Preferably, the amount of diluent/bulking material isfrom about 35% to about 55% by weight of the final composition.

[0088] The rapid-melt, semi-solid compositions of the present inventivesubject matter may optionally contain a further slipping agent to aid inthe palatability of the composition after it melts in the mouth of themammal. The slipping agent may be a further lipid material, as isdescribed above for binders, or another material which aids in the“slipping” of the composition through the mouth and down the esophagusof the mammal.

[0089] As is discussed above, the preferably anhydrous nature of thepresent inventive compositions allows for very high doses of activematerials to be incorporated therein. The amount of active materialpresent in the inventive compositions will vary depending on theparticular active used, but generally will be present in an amount ofabout 0.001% to 70% by weight of the composition. Preferably, the activeingredients used in the inventive compositions are prophylactic ortherapeutic active ingredients. Prophylactic or therapeutic activematerials which can be used in the present invention are varied. Anon-limiting list of such materials includes the following:antitussives, antihistamines, decongestants, alkaloids, mineralsupplements, laxatives, vitamins, antacids, ion exchange resins,anti-cholesterolemics, antiarrhythmics, antipyretics, analgesics,appetite suppressants, expectorants, anti-anxiety agents, anti-ulceragents, anti-inflammatory substances, coronary dilators, cerebraldilators, peripheral vasodilators, anti-infectives, psycho-tropics,antimanics, stimulants, gastrointestinal agents, sedatives, antidrrhealpreparations, anti-anginal drugs, vasodialators, anti-hypertensivedrugs, vasoconstrictors, migraine treatments, antibiotics,tranquilizers, anti-psychotics, antitumor drugs, anticoagulants,antithrombotic drugs, hypontics, anti-emetics, anti-nausants,anti-convulsants, neuromuscular drugs, hyper- and hypoglycemicspasmodics, uterine relaxants, mineral and nutritional additives,antiobesity drugs, anabolic drugs, erythropoetic drugs, antiashmatics,cough suppressants, mucolytics, anti-uricemic drugs and mixturesthereof.

[0090] Preferred prophylactic or therapeutic active materialscontemplated for use in the present inventive subject matter areanalgesics. Examples of analgesics useful in the present inventivesubject matter, and which are the preferred therapeutic activeingredients, include, without limitation, aspirin, acetaminophen,ibuprophen and mixtures thereof.

[0091] Another preferred active material can be selected from the classof prophylactic, abortive or analgesic drugs used to treat migraines.Migraines are defined as headaches that last 4 to 72 hours wherein thepatient experiences moderate to severe cranial throbbing. Migraines arealso associated with nausea, vomiting, or sensitivity to light, sound orsmell.

[0092] For prophylactic treatment of migraines, β-blockers, calciumchannel blockers, tricyclic antidepressants, or anticonvulsants can beused. Examples of drugs indicated for prophylactic treatment includeamitriptyline, methysergide, popranolol, valproate, and verapamil.

[0093] For abortive treatment of migraines serotonin receptor activatorssuch as eletriptan, ergotamine, naratriptan, rizatriptan benzoate,sumatriptan succinate, and zolmitriptan can be used. Ergot alkaloidderivatives such as ergoamine tartrate and dihydroergotamine are alsoeffective. Dopamine antagonist anti-emetics such as metoclopramide andprochlorperazine while indicated for the treatment of nausea, can alsobe used even if nauseau is not prominent.

[0094] For analgesic treatment acetaminophen, aspirin, non-asteroidalanti-inflammatory drugs (“NSAID”) and opioids can be used in the presentinvention.

[0095] In general, any class of drug indicated for migraine treatmentmay be used in the present invention. For example, sumatriptan succinatemay be incorporated into the rapid-melt semi-solid compositions of thepresent invention to effectively deliver sumatriptan succinate to apatient in need thereof. In particular, sumatriptan succinate can beformulated with the present invention in doses ranging from 25, 50, to100 mg daily. All the examples are non-limiting and it will beunderstood that other migraine therapeutics may be used with the presentinventive subject matter.

[0096] Yet another preferred active material used in the composition ofthe present inventive matter is a psychotropic. Psychotropics are usedto treat depression, schizophrenia, anxiety disorders, attention deficitorder, obsessive compulsive disorder, senile dementia and certain sleepdisorders.

[0097] The classes of drugs used in treating depression includeselective serotonin reuptake inhibitors (“SSRI'S”), heterocyclicantidepressants, monoamine oxidase inhibitors (“MAOI's”),serotonergic-noradrenergics, 5-HT₂ antagonists and catecholaminergics.

[0098] Examples of SSRI'S include fluoxetine HCl, sertraline HCl,paroxetine HCl, and fluvoxamine. Examples of heterocyclicantidepressants include amitriptyline, nortriptyline, imipramine,desipramine, doxepin, trimipramine, clomipramine, protriptyline,amoxapine, and maprotiline. Examples of MAOI's include phenelzine andtranylcypromine. An example of a serotonergic-noradrenergics includesvenlafaxine HCl. Examples of 5-HT₂ antagonists include trazadone,nefazodone, and mirtazapine. An example of a catecholaminergics includesbupropion. All examples are non-limiting and it will be understood thatpsychotropics of the disclosed classes may be used with the presentinventive subject matter.

[0099] In general, any class of psychotropic drug indicated for treatingdepression may be used in the present invention. For example, fluoxetineHCl may be incorporated into the rapid-melt semi-solid compositions ofthe present invention to effectively deliver fluoxetine HCl to a patientin need thereof. In particular, fluoxetine HCl can be formulated withthe present invention in doses ranging from about 10 to 60 mg daily. Oneof ordinary skill in the art will be able to determine the proper dosagefor the remaining disclosed drugs.

[0100] For the treatment of anxiety, benzodiazepines may be used withthe present inventive subject matter. Specific examples includealprazolam, chlordiazepoxide, clonazepam, clorazepate, diazepam,lorazepam, and oxazepam. However, any class of psychotropic drugindicated for anxiety treatment may be used in the present invention.

[0101] In particular, alprazolam may be incorporated into the rapid-meltsemi-solid compositions of the present invention to effectively deliveralprazolam to a patient in need thereof. In particular, alprazolam canbe formulated with the present invention in doses ranging from about0.25 to 0.50 mg to be taken three times daily. One of ordinary skill inthe art will be able to determine the proper dosage for the remainingdisclosed drugs.

[0102] For the treatment of insomnia, drugs belonging to the categoriesof benzodiazepines, imidazopyridines, antidepressants andnon-prescription hypnotics may be used with the present inventivesubject matter. Examples of benzodiazepines useful for the treatment ofinsomnia include midazolam, triazolam, oxazepam, temazepam, lorazepam,estazolam, nitrazepam, diazepam, quazepam, flurazepam, zopiclone andclorazepate. An example of an imidazopyridine includes zolpidem andzolpidem tartarate. Examples of antidepressants include amityiptylineand doxepin.

[0103] In particular, zolpidem may be incorporated into the rapid-meltsemi-solid compositions of the present invention to effectively deliverzolpidem to a patient in need thereof. In particular, zolpidem can beformulated with the present invention in doses ranging from about 5.0 to30.0 mg daily, the preferred range being from about 5.0 to 10.0 mgdaily. One of ordinary skill in the art will be able to determine theproper dosage for the remaining disclosed drugs. Moreover, all theexamples are non-limiting and it will be understood that otherpsychotrpoics may be used with the present inventive subject matter.

[0104] Still yet another preferred active material used in thecomposition of the present inventive matter is a gastrointestinaltherapeutic. Gastrointestinal therapeutics are used to treat gastritis,nausea and vomiting, gastroesophegal reflux disease, colitis, Crohn'sdisease and diarrhea. Classes of drugs include proton pump inhibitors,histamine H₂ receptor antagonists, terpene analogs, and NSAID'S.

[0105] For the treatment of gastritis, drugs such as omeprazole,lansoprazole, ranitidine HCl, famotidine, nizatidine, teprenone,cimetidine, rabeprazole sodium, and sulpiride can be used in thecompositions of the present inventive subject matter.

[0106] For the treatment of nausea and vomiting, drugs such asondansetron HCl, granisetron HCl, dolasetron mesylate, and tropisetronmay be used.

[0107] In particular, omeprazole may be incorporated into the rapid-meltsemi-solid compositions of the present invention to effectively deliveromeprazole to a patient in need thereof. In particular, omeprazole canbe formulated with the present invention in doses ranging from about10.0 to 60.0 mg daily, the preferred range being from about 15.0 to 25.0mg daily. One of ordinary skill in the art will be able to determine theproper dosage for the remaining disclosed drugs. Moreover, all theexamples are non-limiting and it will be understood that othergastrointestinal therapeutics may be used with the present inventivesubject matter.

[0108] Another preferred active material used in the compositions of thepresent invention include cardiovascular therapeutics. Cardiovasculartherapeutics treat hypertension, angina, myocardial infarction,congestive heart failure, acute coronary syndrome, edema, ventriculartachycardia, hyperaldosteronism, ventricular arrhythmia, cardiacinsufficiency, atrial fibrillation, arterial occlusion, cardiacdecompensation, and microcirculation activation.

[0109] A related class of cardiovascular therapeutics are cholesterolreducers such as 3-hydroxy-3-methylglutaryl coenzymeA (“HMG-CoA”)reductase inhibitors. HMG-CoA inhibitors work by blocking an enzyme usedto make cholesterol. Blocking cholesterol thereby treatshypercholesterolemia which is a significant cause of cardiovasculardisease.

[0110] For the treatment of hypercholesterolemia, drugs such assimvastin, atorvastatin calcium, pravastatin sodium, pravastatin,lovastatin, fluvastatin sodium, cerivastatin sodium can be used in thecompositions of the present inventive subject matter.

[0111] For the treatment of hypertension, drugs such as amlodipinebesylate, losartan potassium, lisinopril, felodipine, benazepril HCl,ramipril, irbesartan, verapamil HCl, bisoprolol fumarate andhydrochlorothiazide, amlodipine and benazepril HCl, clonidine,candesartan, cilexetil, diltiazem, nicardipine, imidapril, trandolapril,eprosartan mesylate, nilvadipine, verapamil HCl, temocapril, prazosinHCl, isradipine, cilazapril, celiprolol, bisoprolol, betazolol HCl,ramipril, nisoldipine, lisinopril, trandolapril, and nisoldipine can beused in the compositions of the present inventive subject matter.

[0112] For the treatment of congestive heart failure, drugs such asdioxin, carvedilol, spironolactone, trandolapril, and bisoprolol can beused in the compositions of the present inventive subject matter.

[0113] In particular, simvastin may be incorporated into the rapid-meltsemi-solid compositions of the present invention to effectively deliversimvastin to a patient in need thereof. In particular, simvastin can beformulated with the present invention in doses ranging from about 5.0 to80 mg daily. One of ordinary skill in the art will be able to determinethe proper dosage for the remaining disclosed drugs. Moreover, all theexamples are non-limiting and it will be understood that drugs from thedisclosed classes may also be used with the present inventive subjectmatter.

[0114] Still another preferred active material used in the compositionof the present invention is a therapeutic useful for treating allergicrhinitis. The classes of compounds useful for treating allergic rhinitisinclude alkylamines, ethanolamines, ethylenediamines, piperazines,phenothiazine, piperdines, and nonsedating compounds.

[0115] Among the non-sedating compounds that can be used in the presentinvention are loratadine, fexofenadine HCl, certirizine HCl, andastemizole. Other drugs which can also be used are fluticasonepropionate, mometasone furoate, epinastine, beclomethasone dipropionate,triamcinolone acetonide, budesonide, and azelastine.

[0116] In particular, loratadine may be incorporated into the rapid-meltsemi-solid compositions of the present invention to effectively deliverloratadine to a patient in need thereof. In particular, loratadine canbe formulated with the present invention in doses ranging from about 5.0to 15 mg daily, with 15 mg daily being the preferred dosage. One ofordinary skill in the art will be able to determine the proper dosagefor the remaining disclosed drugs. Moreover, all the examples arenon-limiting and it will be understood that other allergic rhinitistherapeutics may be used with the present inventive subject matter.

[0117] Still yet another preferred active material used in thecomposition of the present invention is a therapeutic useful fortreating osteoarthritis or rheumatoid arthritis. Rheumatoid arthritis isdefined as non-specific, symmetrical inflammation of the peripheraljoints, potentially resulting in progressive destruction of articularand periarticular structures. Osteoarthritis is characterized by loss ofarticular cartilage and hypertrophy of bone. Although osteoarthritis isa degenerative bone disease, symptoms associated with rheumatoidarthritis such as inflammation of the joints occur in a patientdiagnosed with osteoarthritis. Accordingly, therapeutics treatingrheumatoid arthritis can also be administered to an osteoarthriticpatient.

[0118] Classes of drugs indicated for osteoarthritis and rheumatoidarthritis include cycloxygenase-2 inhibitors, NSAID'S, biologic responsemodifiers, pyrimidine synthesis inhibitors and hyaluronic acid. Specificexamples of osteoarthritis and rheumatoid arthritis therapeutics includecelecoxib, diclofenac sodium, rofecoxib, nabumetone, diclofenac sodiumand misoprostol, oxaprozin, meloxicam, piroxicam, etodolac, naproxen,hylan G-F 20, leflunomide, tenoxicam, and naproxen sodium.

[0119] In particular, celecoxib may be incorporated into the rapid-meltsemi-solid compositions of the present invention to effectively delivercelecoxib to a patient in need thereof. In particular, celecoxib can beformulated with the present invention in doses ranging from about 150 to250 mg daily, with 200 mg daily being the preferred dosage. One ofordinary skill in the art will be able to determine the proper dosagefor the remaining disclosed drugs. Moreover, all the examples arenon-limiting and it will be understood that other osteoarthritis andrheumatoid arthritis therapeutics from the disclosed classes may also beused with the present inventive subject matter.

[0120] Another preferred active material used in the composition of thepresent invention is a therapeutic useful for treating benign prostatichypertrophy. Benign prostatic hypertrophy is defined as an adenomatoushyperplasia of the periurethral part of the prostrate gland.

[0121] Classes of drug useful for the treatment of benign prostatichypertrophy include alpha blockers, alpha-1 selective adrenoceptorblocking agents and 5-reductase inhibitors. Specific examples of benignprostatic hypertrophy therapeutics include doxazosin mesylate, terazosinHCl, tamsulosin, finasteride, tamsulosin HCl, ethinyl estradiol andlevonorgestrel.

[0122] In particular, doxazosin mesylate may be incorporated into therapid-melt semi-solid compositions of the present invention toeffectively deliver doxazosin mesylate to a patient in need thereof. Inparticular, doxazosin mesylate can be formulated with the presentinvention in doses ranging from about 1 to 16 mg daily. One of ordinaryskill in the art will be able to determine the proper dosage for theremaining disclosed drugs. Moreover, all the examples are non-limitingand it will be understood that other benign prostatic hypertrophytherapeutics from the disclosed classes may also be used with thepresent inventive subject matter.

[0123] Yet another preferred active material used in the composition ofthe present invention is a drug indicated for the treatment of fungalinfections. Classes of drugs indicated for the treatment of fungalinfections include synthetic triazole, ergosterol inhibitor, and polyeneantifungal. Specific examples of drugs indicated for the treatment offungal infections are itraconazole, ketoconazole, and amphotericin B.

[0124] In particular, itraconazole may be incorporated into therapid-melt semi-solid compositions of the present invention toeffectively deliver itraconazole to a patient in need thereof. Inparticular, itraconazole can be formulated with the present invention indoses ranging from about 1.0 to 400 mg daily. One of ordinary skill inthe art will be able to determine the proper dosage for the remainingdisclosed drugs. Moreover, all the examples are non-limiting and it willbe understood that other anti-fungals from the disclosed classes mayalso be used with the present inventive subject matter.

[0125] Still yet another preferred active material used in thecomposition of the present invention is a anti-convulsant.Anti-convulsants are drugs that prevent or relieve convulsions whereinthe convulsions are due to epilepsy, seizure disorders, partial seizuredisorders or Huntington's disease. Classes of drugs useful for treatingthese conditions include gamma-aminobutyric analogs, phenyltriazine,antiepileptic agents, benzodiazepines, polysynaptic response inhibitors,sulfamate-substituted monosaccharides, gamma-amino butyric acid uptakeinhibitors and benzamides. Specific examples include carbamazepine,topiramate, and tigabine HCl.

[0126] In particular, carbamazepine may be incorporated into therapid-melt semi-solid compositions of the present invention toeffectively deliver carbamazepine to a patient in need thereof. Inparticular, carbamazepine can be formulated with the present inventionin doses ranging from about 100 to 1600 mg daily. One of ordinary skillin the art will be able to determine the proper dosage for the remainingdisclosed drugs. Moreover, all the examples are non-limiting and it willbe understood that other anti-convulsants from the disclosed classes mayalso be used with the present inventive subject matter.

[0127] Another preferred active material used in the composition of thepresent invention is an anti-herpetic. Anti-herpetics are used to treatinfections from the varicella-zoster virus. Classes of drugs useful fortreating herpes include synthetic purine nucleoside analogs, nucleosideanalogs, and antiviral agents. Specific examples include acyclovir,valacyclovir HCL and famcyclovir.

[0128] In particular, acyclovir may be incorporated into the rapid-meltsemi-solid compositions of the present invention to effectively deliveracyclovir to a patient in need thereof. In particular, acyclovir can beformulated with the present invention in doses ranging from about 200 to800 mg daily. One of ordinary skill in the art will be able to determinethe proper dosage for the remaining disclosed drugs. Moreover, all theexamples are non-limiting and it will be understood that otheranti-herpetics from the disclosed classes may also be used with thepresent inventive subject matter.

[0129] Yet another active material used in the compositions of thepresent invention are anti-diarrheal therapeutics. Anti-diarrhealtherapeutics treat the condition of diarrhea whether it is symptomaticof the disorder itself wherein diarrhea is a condition that occurs whena mammal has a low amount of stool in a bowel movement. Diarrhea resultsmainly from excess fecal water in the bowel of the mammal. Specificexamples of anti-diarrheal therapeutics include loperamide HCl,diphenoxylate, codeine phosphate, camphorated opium tincture.

[0130] The present inventive subject matter contemplates incorporatingloperamide hydrochloride into the rapid-melt semi-solid compositions asan effective means of delivering the active to a patient in needthereof. The amount of loperamide hydrochloride needed in the willdepend on the intended recipient of the active ingredient. The normaldosage amount for a human adult is initially 4 milligrams, with afollow-up dosage of 2 milligrams after each unformed stool. Forchildren, the normal dosage will depend on the age and weight of thechild, pursuant to the guidelines set forth by the child's physician.

[0131] The use of the present inventive subject matter to deliverloperamide hydrochloride to a child is especially effective since therapid-melt, semi-solid compositions of the present inventive subjectmatter do not require any chewing by the patient. As has been previouslyexplained, the melting feature of the novel compositions makes thecompositions ideal for uses in pediatric and geriatric care, since smallchildren and aged individuals often have difficulty chewing items. Withthis intended use in mind, the compositions may be specially formulatedfor pediatric and geriatric patients. The unique properties will aid indrug compliance by such patients as the drugs may be administered in away that will not require chewing by the patient.

[0132] Further preferred nutritional active materials useful in thepresent inventive subject matter include, without limitation,calcium-containing materials such as calcium carbonate, vitamins,minerals, herbals, spices and mixtures thereof.

[0133] Examples of vitamins that are available as active ingredientsinclude, without limitation, vitamin A (retinol), vitamin D(cholecalciferol), vitamin E group (α-tocopherol and other tocopherols),vitamin K group (phylloquinones and menaquinones), thiamine (vitaminB₁), riboflavin (vitamin B₂), niacin, vitamin B₆ group, folic acid,vitamin B₁₂ (cobalamins), biotin, vitamin C (ascorbic acid), andmixtures thereof. The amount of vitamin or vitamins present in the finalencapsulated product of the present inventive subject matter isdependent on the particular vitamin and is generally the United States'Department of Agriculture Recommended Daily Allowances (USRDA) for thatvitamin. For example, if vitamin C is the active ingredient and theencapsulated product is being used in a confectionery or chewing gumtargeting adults, the amount of vitamin C in the encapsulated productwould be 60 milligrams, which is the USRDA of vitamin C for adults.

[0134] Examples of minerals that are available as active ingredientsinclude, without limitation, calcium, magnesium, phosphorus, iron, zinc,iodine, selenium, potassium, copper, manganese, molybdenum and mixturesthereof. As is the case with vitamins, the amount of mineral or mineralspresent in the final encapsulated product of the present inventivesubject matter is dependent on the particular mineral and is generallythe USRDA for that mineral. For example, if iodine is the activeingredient and the encapsulated product is being used in a confectioneryor chewing gum targeting adults, the amount of iodine in theencapsulated product would be 150 micrograms, which is the USRDA ofiodine for adults.

[0135] Examples of herbals that are available as active ingredientsinclude, without limitation, echinacea, peppermint, licorice,goldenseal, panax pseudoginseng, grapeseed extract, bilberry, kava,ginko biloba, panax quinquefolium, Siberian ginseng, St. John's wort,bromelian, guglupids, hawthorn, garlic, ginger, angelica species,dandelion, goldenseal, and mixtures thereof. Further, examples of spicesthat are available as active ingredients include, without limitation,mustard, dillweed, cinnamon, garlic, black pepper, onion, sage, oregano,basil, cream of tartar, targon, cayenne pepper, red pepper, and mixturesthereof. This list of herbals and spices is for exemplary purposes andis not meant to be construed as limiting the inventive subject matterthereto.

[0136] Many of the active material listed above have unpalatable tastes.Taste-masking of compositions with those unpalatable active materials iswell-known in the art. The use of flavors and sweeteners to mask theunpalatability of the active materials is also well known. Thus, othermaterials which can be incorporated into the rapid-melt, semi-solidmolded composition of the present inventive subject matter includeflavors, colors and sweeteners. A distinct feature of the inventiverapid-melt, semi-solid compositions is that they exhibit excellent tastecharacteristics. Importantly, it is possible to incorporate high levelsof flavors, sweeteners and other taste-masking agents, making thecompositions more palatable when undesirable tastes accompany the activematerials.

[0137] Flavors may be chosen from natural and synthetic flavor liquids.Flavors useful in the present inventive compositions include, withoutlimitation, volatile oils, synthetic flavor oils, flavoring aromatics,oils, liquids, oleoresins or extracts derived from plants, leaves,flowers, fruits, stems and combinations thereof. A non-limiting list ofexamples include citrus oils such as lemon, orange, grape, lime andgrapefruit and fruit essences including apple, pear, peach, grape,strawberry, raspberry, cherry, plum, pineapple, apricot or other fruitflavors.

[0138] Other useful flavorings include aldehydes and esters such asbenzaldehyde (cherry, almond), citral, i.e., alphacitral (lemon, lime),neral, i.e., betal-citral (lemon, lime), decanal (orange, lemon),aldehyde C-8 (citrus fruits), aldehyde C-9 (citrus fruits), aldehydeC-12 (citrus fruits), tolyl aldehyde (cherry, almond),2,6-dimethyloctanal (green fruit), and 2-dodecenal (citrus, mandarin),and mixtures thereof.

[0139] Further examples of flavors useful in the inventive compositionsinclude, without limitation, beef flavorings, chicken flavorings, riceflavorings, lamb flavorings, pork flavorings, seafood flavorings, andmixtures thereof.

[0140] The sweeteners may be chosen from the following non-limitinglist: flucose (corn syrup), dextrose, invert sugar, fructose, andmixtures thereof; saccharin and its various salts such as the sodiumsalt; dipeptide sweeteners such as aspartame; dihydrochalcone compounds,glycyrrhizin; Stevia rebaudiana (Stevioside); chloro derivatives ofsucrose such as sucralose; sugar alcohols such as sorbitol, mannitol,zylitol, and the like. Also contemplated are hydrogenated starchhydrolysates and synthetic sweetener3,6-dihydro-6-methyl-1-1-1,2,3-oxathiazin-4-one-2,2-dioxide,particularly the potassium salt (acesulfame-K) and sodium and calciumsalts thereof. Other sweeteners may also be used.

[0141] The rapid-melt, semi-solid compositions of the present inventivesubject matter may also be coated in order to facilitate handling of thecompositions. Coatings well-known in the art are useful for keeping thecompositions from melting prior to being administered to a patient inneed of an active material. By coating the compositions, the compositionwill maintain its semi-solid state while being handled and will meltwhen inserted into a patient's mouth.

[0142] The present inventive subject matter also contemplates a methodof preparing a rapid-melt, semi-solid molded composition. It should berecognized that the composition may be prepared by a variety of methodswell-known by those of ordinary skill in the art. Such processes may beused on a batch or continuous process format and would involve meltingthe binders and uniformly blending them for suitable periods of timeprior to adding the salivating agent. Once these two components havebeen blended together, the further components may be added eithertogether or sequentially until a uniform mixture is obtained. It shouldbe recognized that the resulting mixture should be in a semi-solid statethat may be poured into a mold, cast into preformed shapes, or stampedinto the final products. Clearly, other tableting techniques arecontemplated to be used herein.

[0143] A particularly preferred method involves the steps of: melting atleast one binder having a melting point about 25 to 45° C. with asalivating agent to form a mixture; mixing an active material with thelipid material to form an active mixture; mixing a diluent/bulkingmaterial with said active material to form a final mixture; and moldingthe final mixture into the semi-solid molded composition. The method ofthe present inventive subject matter also contemplates adding othermaterials to the final mixture prior to molding into the semi-solidmolded composition. Other materials which may be added to the finalmixture prior to molding include, without limitation, flavors, colors,sweeteners, and mixtures thereof.

[0144] The amount of binder melted with the salivating agent is fromabout 10% to about 70% by weight of the final composition. Preferably,the amount of binder is from about 10% to about 50% by weight. Morepreferably the binder is present from about 15% to about 30% by weight.Likewise, the amount of salivating agent melted in the first step of themethod is from about 0.2% to about 0.5% by weight of the finalcomposition. Preferably, the amount of salivating agent is from about0.3% to 0.4% by weight of the composition.

[0145] The rapid-melt, semi-solid compositions of the present inventivesubject matter produced by the above methods have increased productintegrity and stability. The compositions are “storage stable”, meaningthat the compositions are stable in the absence of special handlingprocedures. The inventive compositions are stable both prior topackaging and after packaging. Importantly, the inventive compositionsmaintain their stability and integrity without refrigeration and withouthumidity controls being implemented during handling, packaging andstoring of the products. Additionally, since the compositions exhibitincreased integrity and stability, the compositions can be used in mostof the current economical packages suitable for a global environment.Further, high temperatures are not needed when processing the inventivecompositions. The only heat that needs to be used during processing isto melt the binder prior to mixing with the other elements.

[0146] The following examples are illustrative of preferred embodimentsof the invention and are not to be construed as limiting the inventionthereto. All percentages are given in weight percent, unless otherwisenoted and equal a total of 100%.

EXAMPLES Example #1 Preparation of 25% Calcium Carbonate Semi-SolidMolded Composition

[0147] 60.00 grams of cocoa butter was melted with 0.80 grams oflecithin and 2.00 grams of sorbitan monostearate. 0.2 grams of yellow #5was added to the above mixture after the ingredients had completelymelted. To this mixture was added 50.00 grams of calcium carbonate. Themixture was then mixed for approximately three minutes. Following themixing period, 85.80 grams of sugar and 0.80 grams of liquid peppermintflavor was added to the mixture to form 200.00 grams of the finalmixture. The final mixture was mixed for approximately 5 minutes, untilall of the ingredients had been thoroughly mixed.

[0148] The final mixture was molded into the final product and allowedto set-up. The resultant product contained 25% calcium carbonate.

Example #2 Preparation of 31.50% Calcium Carbonate Semi-Solid MoldedComposition

[0149] 30.00 grams of cocoa butter was melted with 0.6 grams of lecithinand 2.00 grams of sorbitan monstearate. 0.60 grams of red #4 was addedafter the ingredients had completely melted. 0.20 grams ofpolyoxyethylene sorbitol monostearate was then added to the mixture andthe mixture was mixed for 3 minutes. To this mixture was added 31.50grams of calcium carbonate and the mixture was further mixed for another3 minutes. Following the mixing period, 51.30 grams of xylitol powderwas added to the mixture along with 0.80 grams of cherry flavor and 0.60grams of vanilla extract, forming 200.00 grams of final mixture. Thefinal mixture was mixed for approximately 5 minutes, until all of theingredients had been thoroughly mixed.

[0150] The final mixture was molded into the final product and allowedto set-up. The resultant product contained 31.50% calcium carbonate.

Example #3 Preparation of 31.50% Calcium Carbonate Semi-Solid MoldedComposition

[0151] 38.00 grams of cocoa butter was melted with 0.68 grams oflecithin and 2.00 grams of sorbitan monstearate. 0.16 grams of red #40was added after the ingredients had completely melted. The mixture wasmixed for 8 minutes at 120° F. 0.40 grams of polyoxyethylene sorbitanester, 0.40 grams of polyglycerol ester, and 4.00 grams of glycerine(99.7%) were added to the mixture and the mixture was further mixed for2 minutes at 110°. To this mixture was added 63.00 grams of calciumcarbonate and the mixture was further mixed for another 4 minutes.Following the mixing period, 4.00 grams of polyethylene glycol, 85.46grams of sugar 10×, 0.18 grams of aspartame and 0.12 grams of acesulfameK were added to the mixture and the resultant mixture was mixed for 4minutes at 90-110° F. The mixture was removed rom the heat and 0.40grams of vanilla flavoring and 1.20 grams of strawberry flavoring wasadded to the mixture, resulting in 200.00 grams of mixture. The finalmixture was mixed for approximately 5 minutes, until all of theingredients had been thoroughly mixed.

[0152] The final mixture was molded into the final product and allowedto set-up. The resultant product contained 31.50% calcium carbonate.

Example #4 Preparation of 31.50% Calcium Carbonate Semi-Solid MoldedComposition

[0153] 38.00 grams of cocoa butter, 0.80 grams of lecithin, 0.40 gramsof polyoxyethylene sorbitan ester, 2.00 grams of sorbitan monostearate,6.00 grams of polyethylene glycol, 0.16 grams of red #40, and 4.00 gramsof glycerine were mixed at 130° F. for 8 minutes. 63.00 grams of calciumcarbonate was added and the mixture was continuously mixed until thecalcium carbonate had completely dissolved at 130° F. 84.04 grams ofxylitol and 1.6 grams of strawberry flavor were added, resulting in200.00 grams of the final mixture. The mixture was mixed for 10 minutes,until all of the ingredients had been thoroughly mixed.

[0154] The final mixture was molded into the final product and allowedto set-up. The resultant product contained 31.50% calcium carbonate.

Example #5 Preparation of 31.50% Calcium Carbonate Semi-Solid MoldedComposition

[0155] 38.00 grams of cocoa butter, 0.68 grams of lecithin, 2.00 gramsof sorbitan monostearate, and 0.16 grams of red #40 were mixed at 100°F. for 8 minutes. 4.00 grams of polyethylene glycol and 0.40 grams ofpolyoxyethylene sorbitan ester was added to the mixture. The mixture wasmixed for 2 minutes at 110° F. for 2 minutes. 0.40 grams of polyglycerolester and 63.00 grams of calcium carbonate were then added and themixture was mixed for 4 minutes at 90° F. 0.18 grams of aspartame, 0.12grams of acesulfame K and 89.66 grams of sugar 10× were added and themixture was mixed for 8 minutes at 90° F. The mixture was removed fromthe heat and 1.00 gram of strawberry flavoring and 0.40 grams of vanillaflavorings were added, resulting in 200.00 grams of final mixture. Themixture was mixed for 10 minutes, until all of the ingredients had beenthoroughly mixed.

[0156] The final mixture was molded into the final product and allowedto set-up. The resultant product contained 31.50% calcium carbonate.

Example #6 Preparation of 31.50% Calcium Carbonate Semi-Solid MoldedComposition

[0157] 30.0 grams of cocoa butter were mixed with 0.6 grams of lecithin.The mixture was heated to 90° F. for 3 minutes. 2.0 grams of sorbitanmonostearate, 0.2 grams of polyoxyethylenee sorbitan ester, and 4.0grams of polyethylene glycol were added to the mixture. The mixture wasmixed for 2 minutes at 110° F. 63.0 grams of calcium carbonate was addedand the mixture was thoroughly mixed for 10 minutes. 49.1 grams of sugar10×, 0.3 grams of aspartame and 49.1 grams of mannitol were added andthe mixture was mixed until all ingredients were thoroughly mixed. 0.1grams of red #40, 0.6 grams of vanilla flavoring and 1.0 grams ofstrawberry flavoring were added to the mixture, resulting in 200.0 gramsof final mixture. The mixture was mixed for 10 minutes, until all of theingredients had been thoroughly mixed.

[0158] The final mixture was molded into the final product and allowedto set-up. The resultant product contained 31.50% calcium carbonate.

Example #7 Preparation of 31.50% Calcium Carbonate Semi-Solid MoldedComposition

[0159] 30.0 grams of cocoa butter were mixed with 0.6 grams of lecithin.The mixture was heated to 90° F. for 3 minutes. 2.0 grams of sorbitanmonostearate, 0.2 grams of polyoxyethylenee sorbitan ester, and 4.0grams of polyethylene glycol were added to the mixture. The mixture wasmixed for 2 minutes at 110° F. 63.0 grams of calcium carbonate was addedand the mixture was thoroughly mixed for 10 minutes. 98.1 grams ofxylitol and 0.3 grams of aspartame were added and the mixture was mixeduntil all ingredients were thoroughly mixed. 0.2 grams of red #40, 0.6grams of vanilla flavoring and 1.0 grams of strawberry flavoring wereadded to the mixture, resulting in 200.0 grams of final mixture. Themixture was mixed for 10 minutes, until all of the ingredients had beenthoroughly mixed.

[0160] The final mixture was molded into the final product and allowedto set-up. The resultant product contained 31.50% calcium carbonate.

Example #8 Preparation of 13.47% Acetaminophen Semi-Solid MoldedComposition

[0161] 38.00 grams of cocoa butter, 0.80 grams of lecithin and 2.00grams of sorbitan monostearate were melted. 6.00 grams of polyethyleneglycol, 4.00 grams of glycerine and 0.40 grams of polyoxyethylenesorbitan ester were added to the melt. The mixture was mixed for 6minutes at 130° F., then for another 2 minutes at 120° F. 120.80 gramsof xylitol were added to the mixture and mixed for 5 minutes at 120° F.26.94 grams of microencapsulated acetaminophen (coated, 90%acetaminophen) were added to the mixture and the mixture was mixed for 7minutes. 0.16 grams of red #40, 0.40 grams of vanilla flavoring and 0.80grams of strawberry flavoring were added to the mixture, resulting in200.30 grams of final mixture. The mixture was mixed for 10 minutes,until all of the ingredients had been thoroughly mixed.

[0162] The final mixture was molded into the final product and allowedto set-up. The resultant product contained 13.47% acetaminophen.

Example #9 Preparation of 13.57% Acetaminophen Semi-Solid MoldedComposition

[0163] 38.00 grams of cocoa butter, 0.68 grams of lecithin and 2.00grams of sorbitan monostearate were melted. 4.00 grams of polyethyleneglycol, 4.00 grams of glycerine and 0.40 grams of polyoxyethylenesorbitan ester were added to the melt. The mixture was mixed for 6minutes at 130° F., then for another 2 minutes at 120° F. 122.06 gramsof sugar 10×, 0.18 grams of aspartame and 0.12 grams of acesulfame Kwere added to the mixture and mixed for 5 minutes at 120° F. 27.14 gramsof microencapsulated acetaminophen (coated, 90% acetaminophen) wereadded to the mixture and the mixture was mixed for 7 minutes. 0.16 gramsof red #40, 0.40 grams of vanilla flavoring and 0.80 grams of strawberryflavoring were added to the mixture, resulting in 199.94 grams of finalmixture. The mixture was mixed for 10 minutes, until all of theingredients had been thoroughly mixed.

[0164] The final mixture was molded into the final product and allowedto set-up. The resultant product contained 13.57% acetaminophen.

Example #10 Preparation of 13.57% Acetaminophen Semi-Solid MoldedComposition

[0165] 38.00 grams of cocoa butter, 0.68 grams of lecithin and 2.00grams of sorbitan monostearate were melted. 4.00 grams of polyethyleneglycol and 0.40 grams of polyoxyethylene sorbitan ester were added tothe melt. The mixture was mixed for 8 minutes at 120° F., then foranother 2 minutes at 110° F. 125.94 grams of xylitol, 0.18 grams ofaspartame and 0.12 grams of acesulfame K were added to the mixture andmixed for 5 minutes at 120° F. 27.14 grams of microencapsulatedacetaminophen (coated, 90% acetaminophen) were added to the mixture andthe mixture was mixed for 7 minutes. 0.16 grams of red #40, 0.40 gramsof vanilla flavoring and 0.80 grams of strawberry flavoring were addedto the mixture, resulting in 199.82 grams of final mixture. The mixturewas mixed for 10 minutes, until all of the ingredients had beenthoroughly mixed.

[0166] The final mixture was molded into the final product and allowedto set-up. The resultant product contained 13.57% acetaminophen.

Example #11 Preparation of 13.57% Acetaminophen Semi-Solid MoldedComposition

[0167] 190.00 grams of cocoa butter, 3.40 grams of lecithin and 10.00grams of sorbitan monostearate were melted. 20.00 grams of polyethyleneglycol and 2.00 grams of polyoxyethylene sorbitan ester were added tothe melt. The mixture was mixed for 8 minutes at 120° F., then foranother 2 minutes at 110° F. 629.70 grams of xylitol, 0.9 grams ofaspartame and 0.6 grams of acesulfame K were added to the mixture andmixed for 5 minutes at 120° F. 135.70 grams of microencapsulatedacetaminophen (coated, 90% acetaminophen) were added to the mixture andthe mixture was mixed for 7 minutes. 0.8 grams of red #40, 2.00 grams ofvanilla flavoring and 4.00 grams of strawberry flavoring were added tothe mixture, resulting in 999.10 grams of final mixture. The mixture wasmixed for 10 minutes, until all of the ingredients had been thoroughlymixed.

[0168] The final mixture was molded into the final product and allowedto set-up. The resultant product contained 13.57% acetaminophen.

Example #12 Preparation of 2.17% Acetaminophen Semi-Solid MoldedComposition

[0169] 38.00 grams of cocoa butter, 0.68 grams of lecithin and 2.00grams of sorbitan monostearate were melted. 4.00 grams of polyethyleneglycol, 0.40 grams of polyglycerol ester, 4.00 grams of glycerine and0.40 grams of polyoxyethylene sorbitan ester were added to the melt. Themixture was mixed for 8 minutes at 120° F., then for another 2 minutesat 110° F. 143.52 grams of sugar 10×, 0.18 grams of aspartame and 0.12grams of acesulfame K were added to the mixture and mixed for 5 minutesat 120° F. 4.34 grams of microencapsulated acetaminophen (coated, 90%acetaminophen) were added to the mixture and the mixture was mixed for 7minutes. 0.16 grams of red #40, 0.40 grams of vanilla flavoring and 1.20grams of strawberry flavoring were added to the mixture, resulting in199.40 grams of final mixture. The mixture was mixed for 10 minutes,until all of the ingredients had been thoroughly mixed.

[0170] The final mixture was molded into the final product and allowedto set-up. The resultant product contained 2.17% acetaminophen.

Example #13 Preparation of 4.34% Acetaminophen Semi-Solid MoldedComposition

[0171] 38.00 grams of cocoa butter, 0.68 grams of lecithin and 2.00grams of sorbitan monostearate were melted. 4.00 grams of polyethyleneglycol and 0.40 grams of polyoxyethylene sorbitan ester were added tothe melt. The mixture was mixed for 8 minutes at 120° F., then foranother 2 minutes at 110° F. 144.38 grams of sugar 10×, 0.18 grams ofaspartame and 0.12 grams of acesulfame K were added to the mixture andmixed for 5 minutes at 120° F. 8.69 grams of microencapsulatedacetaminophen (coated, 90% acetaminophen) were added to the mixture andthe mixture was mixed for 7 minutes. 0.16 grams of red #40, 0.40 gramsof vanilla flavoring and 1.00 grams of strawberry flavoring were addedto the mixture, resulting in 200.01 grams of final mixture. The mixturewas mixed for 10 minutes, until all of the ingredients had beenthoroughly mixed.

[0172] The final mixture was molded into the final product and allowedto set-up. The resultant product contained 4.34% acetaminophen.

Example #14 Preparation of 31.50% Calcium Carbonate Semi-Solid MoldedComposition

[0173] 19.00 grams of cocoa butter, 0.34 grams of lecithin, 1.00 gramsof sorbitan monostearate, and 0.08 grams of red #40 are mixed at 100° F.for 8 minutes. 2.00 grams of polyethylene glycol, 2.00 grams ofglycerine and 0.20 grams of polyoxyethylene sorbitan ester is added tothe mixture. The mixture is mixed for 2 minutes at 110° F. for 2minutes. 0.20 grams of polyglycerol ester and 31.5 grams of calciumcarbonate are then added and the mixture is mixed for 4 minutes at 90°F. 0.09 grams of aspartame, 0.06 grams of acesulfame K and 42.73 gramsof sugar 10× are added and the mixture is mixed for 8 minutes at 90° F.The mixture is removed from the heat and 0.60 gram of strawberryflavoring and 0.20 grams of vanilla flavorings are added, resulting in100.00 grams of final mixture. The mixture is mixed for 10 minutes,until all of the ingredients have been thoroughly mixed.

[0174] The final mixture is molded into the final product and allowed toset-up. The resultant product contains 31.50% calcium carbonate. Example#15

Preparation of 31.50% Calcium Carbonate Semi-Solid Molded Composition

[0175] 15.00 grams of cocoa butter, 1.00 grams of sorbitan monostearate,and 0.08 grams of red #40 are mixed at 100° F. for 8 minutes. 0.80 gramsof polyoxyethylene sorbitan ester is added to the mixture. The mixtureis mixed for 2 minutes at 110° F. for 2 minutes. 31.5 grams of calciumcarbonate are then added and the mixture is mixed for 4 minutes at 90°F. 51.00 grams of xylitol are added and the mixture is mixed for 8minutes at 90° F. The mixture is removed from the heat and 0.40 gram ofstrawberry flavoring and 0.22 grams of vanilla flavorings are added,resulting in 100.00 grams of final mixture. The mixture is mixed for 10minutes, until all of the ingredients have been thoroughly mixed.

[0176] The final mixture is molded into the final product and allowed toset-up. The resultant product contains 31.50% calcium carbonate. Example#16

Preparation of 31.50% Calcium Carbonate and 13.57% AcetaminophenSemi-Solid Molded Composition

[0177] 15.00 grams of cocoa butter, 0.40 grams of lecithin, and 1.00grams of sorbitan monostearate, are mixed at 100° F. for 8 minutes. 0.20grams of polyoxyethylene sorbitan ester is added to the mixture. Themixture is mixed for 2 minutes at 110° F. for 2 minutes. 0.20 grams ofpolyglycerol ester and 31.50 grams of calcium carbonate are then addedand the mixture is mixed for 4 minutes at 90° F. 0.15 grams ofaspartame, 13.57 grams of coated acetaminophen microcaps (coated, 90%acetaminophen) and 37.18 grams of sugar 10× are added and the mixture ismixed for 8 minutes at 90° F. The mixture is removed from the heat and0.80 grams of strawberry flavoring are added, resulting in 100.00 gramsof final mixture. The mixture is mixed for 10 minutes, until all of theingredients have been thoroughly mixed.

[0178] The final mixture is molded into the final product and allowed toset-up. The resultant product contains 31.50% calcium carbonate and13.57% acetaminophen.

Example #17 Preparation of 13.57% Acetaminophen Semi-Solid MoldedComposition

[0179] 19.00 grams of cocoa butter, 0.34 grams of lecithin, 1.00 gramsof sorbitan monostearate, and 0.08 grams of red #40 are mixed at 100° F.for 8 minutes. 2.00 grams of polyethylene glycol are added to themixture. The mixture is mixed for 2 minutes at 110° F. for 2 minutes.13.57 grams of coated acetaminophen microcaps (coated, 90%acetaminophen) are then added and the mixture is mixed for 4 minutes at90° F. 0.15 grams of aspartame and 63.26 grams of sugar 10× are addedand the mixture is mixed for 8 minutes at 90° F. The mixture is removedfrom the heat and 0.40 gram of strawberry flavoring and 0.20 grams ofvanilla flavorings are added, resulting in 100.00 grams of finalmixture. The mixture is mixed for 10 minutes, until all of theingredients have been thoroughly mixed.

[0180] The final mixture is molded into the final product and allowed toset-up. The resultant product contains 13.57% acetaminophen.

Example #18 Preparation of 4.34% Acetaminophen Semi-Solid MoldedComposition

[0181] 19.00 grams of cocoa butter, 0.34 grams of lecithin, 1.00 gramsof sorbitan monostearate, and 0.08 grams of red #40 are mixed at 100° F.for 8 minutes. 2.00 grams of polyethylene glycol is added to themixture. The mixture is mixed for 2 minutes at 110° F. for 2 minutes.0.20 grams of polyglycerol ester and 4.34 grams of coated acetaminophenmicrocaps (coated, 90% acetaminophen) are then added and the mixture ismixed for 4 minutes at 90° F. 0.15 grams of aspartame and 72.19 grams ofsugar 10× are added and the mixture is mixed for 8 minutes at 90° F. Themixture is removed from the heat and 0.50 grams of strawberry flavoringand 0.20 grams of vanilla flavorings are added, resulting in 100.00grams of final mixture. The mixture is mixed for 10 minutes, until allof the ingredients have been thoroughly mixed.

[0182] The final mixture is molded into the final product and allowed toset-up. The resultant product contains 4.34% acetaminophen.

Example #19 Preparation of 10.50% Ibuprofen Semi-Solid MoldedComposition

[0183] 19.00 grams of cocoa butter, 0.34 grams of lecithin, 1.00 gramsof sorbitan monostearate, and 0.08 grams of red #40 are mixed at 100° F.for 8 minutes. 2.00 grams of polyethylene glycol, 2.00 grams ofglycerine and 0.20 grams of polyoxyethylene sorbitan ester is added tothe mixture. The mixture is mixed for 2 minutes at 110° F. for 2minutes. 0.20 grams of polyglycerol ester and 10.50 grams of coatedibuprofen microcaps (coated, 50% ibuprofen) are then added and themixture is mixed for 4 minutes at 90° F. 0.15 grams of aspartame and62.13 grams of sugar 10× are added and the mixture is mixed for 8minutes at 90° F. The mixture is removed from the heat and 0.60 gram ofstrawberry flavoring, 0.20 grams of vanilla flavoring and 1.60 grams offruit flavoring are added, resulting in 100.00 grams of final mixture.The mixture is mixed for 10 minutes, until all of the ingredients havebeen thoroughly mixed.

[0184] The final mixture is molded into the final product and allowed toset-up. The resultant product contains 10.50% ibuprofen.

Example #20 Preparation of 10.85 mg Dose Loperamide HydrochlorideSemi-Solid Molded Composition

[0185] The inventive subject matter containing loperamide hydrochloridecan be made by the following process. 72.00 grams of cocoa butter, 2.00grams of lecithin, 4.40 grams of sorbitan monostearate, and 24.00 gramsof kaomel are mixed at 100° F. for 8 minutes. 12.00 grams of MCT oil and0.80 grams of Polysorbate 80 are added to the mixture. The mixture ismixed for 2 minutes at 110° F. 0.20 grams of sodium laurel sulfate and2.17 grams of loperamide hydrochloride are then added and the mixture ismixed for 4 minutes at 90° F. 1.20 grams of aspartame and 263.60 gramsof sugar 10× are added and the mixture It is mixed for 8 minutes at 90°F. The mixture is removed from the heat and 0.10 grams of light greencoloring (0.01 grams of 0.0025% Blue #1 and 0.09 grams of 0.0225% Yellow#5), 1.80 grams of vanilla flavoring, 0.40 grams of flavor enhancer,2.00 grams of natural cream powder and 13.32 grams of instant releasepeppermint are added, resulting in 400.00 grams of final mixture. Themixture is mixed for 10 minutes, until all of the ingredients have beenthoroughly mixed.

[0186] The final mixture is molded into the final product and allowed toset-up. The final product is then cut into 200 evenly-sized pieces. Eachpiece of product contains 10.85 mg loperamide hydrochloride.

Example #21 Preparation of 10 mg Dose Omeprazole Semi-Solid MoldedComposition

[0187] The inventive subject matter containing omeprazole can be made bythe following process. 70.00 grams of cocoa butter, 2.00 grams oflecithin, 4.40 grams of sorbitan monostearate, and 24.00 grams of kaomelare mixed at 100° F. for 8 minutes. 12.00 grams of MCT oil and 0.80grams of Polysorbate 80 are added to the mixture. The mixture is mixedfor 2 minutes at 110° F. 0.20 grams of sodium laurel sulfate and 2.00grams of omeprazole are then added and the mixture is mixed for 4minutes at 90° F. 1.20 grams of aspartame and 263.60 grams of sugar 10×are added and the mixture is mixed for 8 minutes at 90° F. The mixtureis removed from the heat and 0.10 grams of light green coloring (0.01grams of 0.0025% Blue #1 and 0.09 grams of 0.0225% Yellow #5), 1.80grams of vanilla flavoring, 0.40 grams of flavor enhancer, 2.00 grams ofnatural cream powder and 13.32 grams of instant release peppermint areadded, resulting in 400.00 grams of final mixture. The mixture is mixedfor 10 minutes, until all of the ingredients have been thoroughly mixed.

[0188] The final mixture is molded into the final product and allowed toset-up. The final product is then cut into 200 evenly-sized pieces. Eachpiece of product contains 10 mg omeprazole.

Example #22 Preparation of 10 mg Dose Sumatriptan Succinate Semi-SolidMolded Composition

[0189] The inventive subject matter containing sumatriptan succinate canbe made by the following process. 70.00 grams of cocoa butter, 2.00grams of lecithin, 4.40 grams of sorbitan monostearate, and 24.00 gramsof kaomel are mixed at 100° F. for 8 minutes. 12.00 grams of MCT oil and0.80 grams of Polysorbate 80 are added to the mixture. The mixture ismixed for 2 minutes at 110° F. 0.20 grams of sodium laurel sulfate and2.00 grams of sumatriptan succinate are then added and the mixture ismixed for 4 minutes at 90° F. 1.20 grams of aspartame and 263.60 gramsof sugar 10× are added and the mixture is mixed for 8 minutes at 90° F.The mixture is removed from the heat and 0.10 grams of light greencoloring (0.01 grams of 0.0025% Blue #1 and 0.09 grams of 0.0225% Yellow#5), 1.80 grams of vanilla flavoring, 0.40 grams of flavor enhancer,2.00 grams of natural cream powder and 13.32 grams of instant releasepeppermint are added, resulting in 400.00 grams of final mixture. Themixture is mixed for 10 minutes, until all of the ingredients have beenthoroughly mixed.

[0190] The final mixture is molded into the final product and allowed toset-up. The final product is then cut into 200 evenly-sized pieces. Eachpiece of product contains 10 mg sumatriptan succinate.

Example #23 Preparation of 60 mg Dose Fluoxetine HydrochlorideSemi-Solid Molded Composition

[0191] The inventive subject matter containing fluoxetine hydrochloridecan be made by the following process. 60.00 grams of cocoa butter, 2.00grams of lecithin, 4.40 grams of sorbitan monostearate, and 24.00 gramsof kaomel are mixed at 100° F. for 8 minutes. 12.00 grams of MCT oil and0.80 grams of Polysorbate 80 are added to the mixture. The mixture ismixed for 2 minutes at 110° F. 0.20 grams of sodium laurel sulfate and12 grams of fluoxetine hydrochloride are then added and the mixture ismixed for 4 minutes at 90° F. 1.20 grams of aspartame and 263.60 gramsof sugar 10× are added and the mixture is mixed for 8 minutes at 90° F.The mixture is removed from the heat and 0.10 grams of light greencoloring (0.01 grams of 0.0025% Blue #1 and 0.09 grams of 0.0225% Yellow#5), 1.80 grams of vanilla flavoring, 0.40 grams of flavor enhancer,2.00 grams of natural cream powder and 13.32 grams of instant releasepeppermint are added, resulting in 400.00 grams of final mixture. Themixture is mixed for 10 minutes, until all of the ingredients have beenthoroughly mixed.

[0192] The final mixture is molded into the final product and allowed toset-up. The final product is then cut into 200 evenly-sized pieces. Eachpiece of product contains 60 mg fluoxetine hydrochloride.

[0193] The inventive subject matter being thus described, it will beobvious that the same may be varied in many ways. Such variations arenot to be regarded as a departure from the spirit and scope of theinventive subject matter, and all such modifications are intended to beincluded within the scope of the following claims.

What is claimed is:
 1. A rapid melt, semi-solid molded compositioncomprising: at least one binder in an amount from about 0.01% to about70% by weight; a salivating agent in an amount from about 0.05% to about15% by weight; a diluent/bulking material in an amount from about 10% toabout 90% by weight; and a therapeutically effective amount of a drug,wherein said drug is selected from the group consisting ofpsychotropics, gastrointestinal therapeutics, cardiovasculartherapeutics, migraine therapeutics, inflammation therapeutics, benignprostatic hypertrophy therapeutics, fungal therapeutics, allergicrhinitis therapeutics, anticonvulsants, and viral therapeutics.
 2. Thecomposition of claim 1, wherein the said drug is a psychotropic.
 3. Thecomposition of claim 2, wherein said psychotropic is a anti-anxietytherapeutic.
 4. The composition of claim 2, wherein said psychotropic isan insomnia therapeutic.
 5. The composition of claim 2, wherein saidpsychotropic is an antidepressant.
 6. The composition of claim 5,wherein said antidepressant is selected from the group consisting ofFluoxetine HCl, Paroxetine HCl, Sertraline HCl, and Venlafaxine HCl,Amitriptyline, Nortriptyline, Imipramine, Desipramine, Doxepin,Trimipramine, Clomipramine, Protriptyline, Amoxapine, Maprotiline,Phenelzine, Tranylcypromine, Fluvoxamine, Venlafaxine, Trazodone,Nefazodone, Mirtazapine, Bupropion, or mixtures thereof.
 7. Thecomposition of claim 6, wherein said drug is Fluoxetine HCl.
 8. Thecomposition of claim 1, wherein said drug is a gastrointestinaltherapeutic.
 9. The composition of claim 8, wherein saidgastrointestinal therapeutic is a ulcer therapeutic.
 10. The compositionof claim 9, wherein said ulcer therapeutic is selected from the groupconsisting of Omeprazole, Lansoprazole, Ranitidine HCl, Famotidine,Nizatidine, Teprenone, Cimetidine, Rabeprazole sodium, Sulpiride, ormixtures thereof.
 11. The composition of claim 10, wherein said ulcertherapeutic is Omeprazole.
 12. The composition of claim 8, wherein saidgastrointestinal therapeutic is a anti-emetic.
 13. The composition ofclaim 12, wherein said anti-emetic is selected from the group consistingOf Ondansetron HCl, Granisetron HCl, Tropisetron, Dolasetron mesylate,Cisapride, Sulfasalazine, Balsalazide, Infliximab, or mixtures thereof.14. The composition of claim 8, wherein said gastrointestinaltherapeutic is a anti-diarrheal therapeutic.
 15. The composition ofclaim 14, wherein said anti-diarrheal therapeutic is selected from thegroup consisting of Loperamide HCl, diphenoxylate, codeine phosphate,camphorated opium tincture, or mixtures thereof.
 16. The composition ofclaim 15, wherein said anti-diarrheal therapeutic is Loperamide HCl. 17.The composition of claim 1, wherein said drug is a migraine therapeutic.18. The composition of claim 17, wherein said migraine therapeutic isselected from the group consisting of sumatriptan succinate,amitripyline, methysergide, propranolol, valproate, verapamil,dihydroergotamine, ergotamine, metoclopramide, naratriptan,prochlorperazine, rizatriptan benzoate, zolmitriptan, eletriptan,acetaminophen, aspirin, NSAID's, opioids, or mixtures thereof.
 19. Thecomposition of claim 18, wherein said migraine therapeutic issumatriptan succinate.
 20. A method of preparing a rapid-melt,semi-solid molded composition comprising the steps of: a) melting atleast one binder in an amount from about 0.01% to about 70% by weightwith a salivating agent in an amount from about 0.05% to about 15% byweight, to form a mixture; b) mixing a therapeutically effective amountof a drug with said mixture to form an active mixture; said drugselected from the group consisting of psychotropics, gastrointestinaltherapeutics, cardiovascular therapeutics, migraine therapeutics,inflammation therapeutics, benign prostatic hypertrophy therapeutics,fungal therapeutics, allergic rhinitis therapeutics, anticonvulsants,and viral therapeutics. c) mixing a diluent/bulking material with saidactive mixture to form a final mixture; and d) molding said finalmixture into said rapid-melt, semi-solid molded composition.
 21. Themethod of claim 20, wherein said drug is a psychotropic.
 22. The methodof claim 21, wherein said psychotropic is selected from the groupconsisting of Fluoxetine HCl, Paroxetine HCl, Sertraline HCl, andVenlafaxine, Amitriptyline, Nortriptyline, Imipramine, Desipramine,Doxepin, Trimipramine, Clomipramine, Protriptyline, Amoxapine,Maprotiline, Phenelzine, Tranylcypromine, Fluvoxamine, Venlafaxine,Trazodone, Nefazodone, Mirtazapine, Bupropion, or mixtures thereof. 23.The method of claim 22, wherein said psychotropic is Fluoxetine HCl. 24.The method of claim 20, wherein said drug is a gastrointestinaltherapeutic.
 25. The method of claim 24, wherein said gastrointestinaltherapeutic is a ulcer therapeutic.
 26. The method of claim 25, whereinsaid ulcer therapeutic is selected from the group consisting ofOmeprazole, Lansoprazole, Ranitidine HCL, Famotidine, Nizatidine,Teprenone, Cimetidine, Rabeprazole sodium, Sulpiride, or mixturesthereof.
 27. The method of claim 26, wherein said ulcer therapeutic isOmeprazole.
 28. The method of claim 24, wherein said gastrointestinaltherapeutic is a anti-emetic.
 29. The method of claim 28, wherein saidanti-emetic is selected from the group consisting of Ondansetron HCl,Granisetron HCl, Tropisetron, Dolasetron mesylate, Cisapride,Sulfasalazine, Balsalazide, Infliximab, or mixtures thereof.
 30. Themethod of claim 24, wherein said gastrointestinal therapeutic is aanti-diarrheal therapeutic.
 31. The method of claim 30, wherein saidanti-diarrheal therapeutic is selected from the group consisting ofLoperamide HCl, diphenoxylate, codeine phosphate, camphorated opiumtincture, or mixtures thereof.
 32. The method of claim 31, wherein saidanti-diarrheal therapeutic is Loperamide HCl.
 33. The method of claim20, wherein said drug is a migraine therapeutic.
 34. The method of claim33, wherein said migraine therapeutic is selected from the groupconsisting of sumatriptan succinate, amitripyline, methysergide,propranolol, valproate, verapamil, dihydroergotamine, ergotamine,metoclopramide, naratriptan, prochlorperazine, rizatriptan benzoate,zolmitriptan, eletriptan, acetaminophen, aspirin, NSAID's, opioids, ormixtures thereof.
 35. The method of claim 34, wherein said migrainetherapeutic is sumatriptan succinate.
 36. A method for treatingdepression, anxiety or insomnia comprising the step of administering toa patient in need thereof a pharmaceutical composition comprising: atleast one binder in an amount from about 0.01% to about 70% by weight; asalivating agent in an amount from about 0.05% to about 15% by weight; adiluent/bulking material in an amount from about 10% to about 90% byweight; a therapeutically effective amount of an anti-depressant,anti-anxiety therapeutic or an insomnia therapeutic and wherein saidcomposition is prepared in the absence of free water.
 37. A method fortreating diarrhea and nausea comprising the step of administering to apatient in need thereof a pharmaceutical composition comprising: atleast one binder in an amount from about 0.01% to about 70% by weight; asalivating agent in an amount from about 0.05% to about 15% by weight; adiluent/bulking material in an amount from about 10% to about 90% byweight; a therapeutically effective amount of an gastrointestinaltherapeutic, a anti-emetic or a anti-diarrheal therapeutic and whereinsaid composition is prepared in the absence of free water.
 38. A methodfor treating migraines comprising the step of administering to a patientin need thereof a pharmaceutical composition comprising: at least onebinder in an amount from about 0.01% to about 70% by weight; asalivating agent in an amount from about 0.05% to about 15% by weight; adiluent/bulking material in an amount from about 10% to about 90% byweight; a therapeutically effective amount of an migraine therapeuticand wherein said composition is prepared in the absence of free water.